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About
This study is being done to see if patients receiving chemotherapy for breast cancer affects the heart, the ability to exercise and fatigue when compared to patients who do not have cancer.
Full description
840 women aged ≥18 years old scheduled to receive chemotherapy for Stage I-III breast cancer and a comparison population of 160 women without cancer (1,000 total). Equal numbers of women will be recruited aged < 52 vs. > 52. At baseline, innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers will be collected.
Measurements will be repeated at 3±1, 12±2 and 24±2 months. This study will assess the relevance of pre-existing factors such as age, black/white race, hypertension, smoking (yes/no), diabetes, coronary artery disease, menopause status, CV medications, and physical activity on the study outcomes. Also, this study will assess dynamic change in modifiable CV risk factors (including BMI, blood pressure, serum lipids, serum glucose, physical activity, psychosocial factors, lifestyle behaviors), and the cancer treatment including chemotherapy, radiation therapy, immunotherapy, and surgery.
Enrollment
Sex
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Inclusion and exclusion criteria
Inclusion Criteria for Women with Stage I - III Breast Cancer:
Exclusion Criteria for Women with Stage I-III Breast Cancer:
Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices (patients with tissue expanders will not be excluded)
If previously measured, known LVEF <50%
Symptomatic claustrophobia
Unable to provide informed consent
At the beginning of the study, pregnant women and women who are breast-feeding will not be enrolled.
Severe pulmonary hypertension
Within the past 6 months:
Within the past month:
Patient does not understand English
Inclusion Criteria for Women Free of Cancer for Comparison:
Exclusion Criteria for Women Free of Cancer for Comparison:
Inflammatory conditions such as lupus or inflammatory bowel disease
Overt coronary artery disease or heart failure
Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices
Symptomatic claustrophobia
Unable to provide informed consent
At the beginning of the study, pregnant women or women who are breast feeding will not be enrolled.
Severe pulmonary hypertension
Within the past 6 months:
Within the past month:
Patient does not understand English
Primary purpose
Allocation
Interventional model
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403 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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